Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

Completed · Phase 1/Phase 2

Conditions studied: Leg Ulcer, Varicose Ulcer

In brief

This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.

Key facts

Study ID: NCT00399308
Run by: Shire
People needed: 40
Starts: 2007-01-31
Expected to finish: 2008-04-30
Last updated by the study team: 2021-06-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

venous ulcer > 1 month and < 12 months in duration; 2 to 20 sq cm in surface area; not infected
confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
ankle-brachial index 0.80 or greater

You may not qualify if…

cutaneous malignancy
recent treatment with corticosteroids or chemotherapeutic agents
wound exposed bone, tendon or neurovascular structure
wound infected and requiring antibiotics

Where it is running

Dr. Robert Snyder — Tamarac, Florida, United States
National Center for Limb Preservation — Niles, Illinois, United States
Beth Israel Deaconess Medical Center, Division of Podiatry — Boston, Massachusetts, United States
State University of New York Stony Brook — Stony Brook, New York, United States
Center for Curative & Palliative Wound Care, Calvary Hospital — The Bronx, New York, United States
University of North Carolina at Chapel Hill, Division of Vascular Surgery — Durham, North Carolina, United States
Blair Medical Associates, Inc., Station Medical Center, Associates Wound Clinic — Altoona, Pennsylvania, United States
Peripheral Vascular Associates, P.A. — San Antonio, Texas, United States
Dixie Regional Medical Center, Wound Care — St. George, Utah, United States

Full record on ClinicalTrials.gov

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